KETOPROFEN DOMPE 25 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the Patient.

Ketoprofen Dompe 25 mg Effervescent Tablets

Ketoprofen

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days of fever and after 5 days of pain.

Contents of the Package Leaflet

1. What is Ketoprofen Dompe and what is it used for
2. What you need to know before taking Ketoprofen Dompe
3. How to take Ketoprofen Dompe
4. Possible side effects
5. Storage of Ketoprofen Dompe
6. Package Contents and Additional Information

1. What is Ketoprofen Dompe and what is it used for

The active ingredient of this medication is ketoprofen lysine salt, which belongs to a group of medications called "Non-Steroidal Anti-Inflammatory Drugs" (NSAIDs). These medications provide short-term relief by changing the body's response to pain, inflammation, and fever. Ketoprofen lysine salt is a salt of ketoprofen that the body absorbs quickly and completely. This medication is indicated in adults 18 years and older, for the symptomatic relief of mild to moderate pain, such as muscle and joint pain, headache, throat irritation pain, dental pain, and menstrual pain, and fever.

You should consult a doctor if your condition worsens or does not improve after 3 days of fever and after 5 days of pain.

2. What you need to know before taking Ketoprofen Dompe

Do not take Ketoprofeno Dompe:

• if you are allergic (hypersensitive) to any of the other components of this medication (listed in section 6)
• if you have asthma or have a history of allergic reactions (hypersensitivity) to ketoprofen or any other NSAID (e.g., acetylsalicylic acid, ibuprofen)
• during the third trimester of pregnancy (from week 29 onwards). See section 2 "Pregnancy and Breastfeeding".
• if you have serious heart problems where your heart does not work as well as it should
• if you suffer from or have a history of intestinal problems, such as:

or active peptic ulcer

or stomach or intestinal ulcers

or intestinal bleeding

or holes in the stomach or gastrointestinal tube (gastrointestinal perforation)

or any conditions caused by treatment with NSAIDs

or painful or altered digestion, which may include nausea, vomiting, stomach acid, abdominal distension, and stomach discomfort (chronic dyspepsia)

or inflammation of the stomach lining (gastritis)

• If you have a low blood cell count (leukopenia or thrombocytopenia), active bleeding, or a tendency to bleed with the treatment of blood clot prevention medications (anticoagulants)
• If you have serious kidney or liver problems.

Warnings and Precautions

If you notice signs of skin rash, red and painful skin around body openings (mucous membranes), or allergic reactions after taking Ketoprofeno Dompe, stop taking this medication and inform your doctor immediately.

If you notice any signs of stomach or intestinal bleeding (e.g., bright red stools, black tarry stools, vomiting blood or dark particles that look like coffee grounds), stop taking this medication and inform your doctor immediately.

If you notice any signs of ulceration or perforation (symptoms may include: severe stomach pain, chills, nausea, vomiting, heartburn) after taking Ketoprofeno Dompe, stop taking this medication and inform your doctor immediately.

Elderly people may experience more side effects with NSAIDs, especially stomach and intestinal side effects, which can be fatal. If you are an elderly patient, the product should be used with caution.

Side effects can be minimized by taking lower doses for the shortest necessary time to relieve symptoms.

Anti-inflammatory/analgesic medications, such as ketoprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses and for prolonged periods. Do not exceed the recommended dose or treatment duration.

Consult your doctor or pharmacist before taking this medication if you have high blood pressure, if your heart is weakened, or if you have arterial disease and/or problems with blood vessels that supply the brain, or if you have a higher risk of contracting such a disease (e.g., if you have diabetes, high cholesterol levels in the blood, or if you smoke).

If you experience palpitations, which are sensations of rapid, uncomfortable, and irregular heartbeats, inform your doctor.

The use of this medication with other products containing NSAIDs (e.g., ibuprofen, aspirin, celecoxib) should be avoided.

Stop taking this medication if you experience any vision problems, such as blurred vision.

Since Ketoprofeno Dompe is used to treat symptoms such as fever, it may mask a more serious underlying condition. If your symptoms persist, inform your doctor.

Taking a pain reliever to relieve headaches for a long time can worsen them.

Consult your doctor or pharmacist before starting to take Ketoprofeno Dompe:

• If you are pregnant, trying to become pregnant, or breastfeeding (see section 2 "Pregnancy and Breastfeeding")
• If you suffer from fluid retention and swelling.
• If you have any blood disorder (e.g., anemia)
• If you have liver disease.
• If you suffer from kidney disease.
• If you have allergies (e.g., hay fever)
• If you have hepatic porphyria (a rare blood disorder characterized by altered activity of one of the liver enzymes) because the medication could trigger an attack.
• If you have an infection; see the "Infections" heading below.

Infections

Ketoprofen may hide the signs of an infection, such as fever and pain. Consequently, this medication may delay the proper treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Children and Adolescents

Ketoprofeno Dompe should not be administered to children under 18 years of age.

Other Medications and Ketoprofeno Dompe

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medication. This includes medications without a prescription or herbal medicines.

You must inform your doctor or pharmacistif you are taking any of the following medications:

• Medications to improve blood flow, such as anticoagulants (aspirin, warfarin, heparin, policosanol, dabigatran, or clopidogrel), thrombolytics (reteplase, streptokinase), pentoxifylline, prasugrel, coumarins.
• certain antibiotics (e.g., quinolones, sulfonamides)
• medications used after organ transplantation to help prevent rejection (e.g., cyclosporine, tacrolimus)
• medications used for certain types of mental illness and depression (e.g., lithium, venlafaxine, and selective serotonin reuptake inhibitors (SSRIs))
• other NSAIDs (e.g., aspirin, ibuprofen) or paracetamol
• diuretics such as bendroflumethiazide
• glucocorticosteroids (steroid hormones such as hydrocortisone or prednisolone)
• antiretroviral medications used to treat HIV infections (e.g., ritonavir, zidovudine)
• medications to treat high blood pressure (e.g., ramipril, captopril, enalapril, losartan, irbesartan)
• muscle relaxants such as baclofen
• medications used to treat heart failure and to control heart rate (e.g., digoxin, digitoxin)
• medications to treat diabetes (e.g., gliclazide)
• medications used to treat cancer (e.g., erlotinib, pemetrexed, methotrexate)
• medications used to treat gout (e.g., probenecid)
• diphenylhydantoin - an antiepileptic medication
• penicillamine: a medication used for the treatment of rheumatoid arthritis
• gemeprost (a medication for gynecological problems)

Taking Ketoprofeno Dompe with Alcohol

Alcohol may cause irritation of the throat, stomach, and intestines; therefore, there is a higher risk of bleeding and ulceration, and this risk increases when NSAIDs are taken at the same time.

Pregnancy and Breastfeeding

Do not take this medication if you are in the third trimester of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your or your child's predisposition to suffer from bleeding and prolong or delay delivery longer than expected. Ketoprofeno Dompe should not be used during the first six months of pregnancy unless the clinical situation of the woman requires treatment with ketoprofen. If during this period or while you plan to become pregnant, you need treatment, the lowest dose should be used for the shortest possible time. If you take ketoprofen during some days from week 20 of pregnancy onwards, it may cause kidney problems in the fetus, which may lead to a reduction in the volume of amniotic fluid surrounding the fetus (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) of the fetal heart. If you need treatment for more than a few days, your doctor will recommend closer monitoring.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Using Machines

If after taking Ketoprofeno Dompe you feel drowsy, dizzy, have blurred vision, or have convulsions, do not drive, use machinery, or perform activities that require a high level of alertness (see section 4 "Possible Side Effects").

Ketoprofeno Dompe Contains Sodium

This medication contains 322 mg of sodium (main component of table/cooking salt) in each tablet. This is equivalent to 16% of the maximum recommended daily sodium intake for an adult.

Ketoprofeno Dompe Contains Sorbitol

This medication contains 147 mg of sorbitol in each tablet.

Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

3. How to Take Ketoprofeno Dompe

Follow the administration instructions for this medication indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

The lowest effective dose should be used for the shortest necessary time to relieve symptoms. If you have an infection, consult your doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose is 1 tablet up to 3 times a day, as needed.

Wait at least 4 hours before taking another tablet.

Do not exceed the recommended dose.

Dissolve 1 tablet in a glass of water before administration.

If the symptoms persist or the pain worsens, or if new symptoms appear, consult your doctor or pharmacist.

Use in Children

Ketoprofeno Dompe should not be taken by children under 18 years of age.

Use in Elderly Patients

Do not take more than 1 tablet of Ketoprofeno Dompe in 24 hours.

If You Take More Ketoprofeno Dompe Than You Should

If you accidentally take more Ketoprofeno Dompe than recommended, you may feel drowsy or nauseous. You should seek medical attention immediately, even if you feel well.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Ketoprofeno Dompe

Do not take a double dose to make up for forgotten doses.

If you forget to take Ketoprofeno Dompe, take it as soon as possible. Do not take a double dose to make up for the forgotten dose, and make sure to leave a minimum of 4 hours between doses and do not exceed the maximum of 3 tablets per day.

If You Stop Taking Ketoprofeno Dompe

You should stop taking this medication as soon as you feel better.

If you have any other doubts about the use of this medication, ask a doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop taking Ketoprofeno Dompe and seek medical attention immediatelyif at any time during treatment with Ketoprofeno Dompe, you develop:

• signs of intestinal bleeding such as: bright red stools, black tarry stools, vomiting blood or dark particles that look like coffee grounds
• signs of skin rash, severe skin reactions, and blisters on the skin, mouth, and eyes
• signs of a severe allergic reaction, such as:
• unexplained difficulty breathing or wheezing
• dizziness or faster heartbeats
• swelling of your lips, face, throat, or tongue
• a worsening of Crohn's disease and colitis (a chronic inflammatory disease of the intestine with symptoms of abdominal pain, diarrhea, fever, and weight loss).

Inform your doctor if you experience:

• fever, sore throat, mouth ulcers, headache, vomiting, unexplained bleeding, and bruising, severe fatigue
• indigestion, stomach or abdominal pain, constipation, diarrhea, flatulence, or if you feel sick, chest pain, or irregular rapid heartbeats
• kidney and liver problems associated with swelling in the arms and legs.

The side effects of Ketoprofeno Dompe may include:

Frequent(may affect up to 1 in 10 people)

• indigestion (dyspepsia), nausea, abdominal pain, vomiting

Uncommon(may affect up to 1 in 100 people)

• headache, dizziness, drowsiness
• constipation, diarrhea, flatulence (gas), inflammation of the stomach lining
• swelling due to fluid accumulation
• itching and rashes
• fatigue

Rare(may affect up to 1 in 1,000 people)

• iron deficiency (anemia) caused by bleeding
• tingling, numbness
• blurred vision
• ringing in the ear (tinnitus)
• asthma
• inflammation of the mouth lining
• stomach ulcer
• inflammation of the liver (hepatitis), increased liver enzymes, yellowing of the skin or the white part of the eyes (jaundice)
• weight gain

Frequency Not Known(frequency cannot be estimated from available data)

• change in blood cell count and platelets
• allergic reactions (anaphylaxis)
• adrenal gland disorders
• high blood pressure, hot flashes (vasodilation)
• heart failure
• kidney failure, kidney inflammation, abnormal kidney test results
• colitis
• worsening of gastrointestinal condition
• dark or black stools
• vomiting blood
• stuffy and runny nose (rhinitis)
• swelling of the throat
• swelling of the deep layers of the skin, caused by excess fluid (e.g., face, hands)
• difficulty breathing (dyspnea)
• headache
• difficulty breathing caused by narrowing of the airways
• uncontrolled muscle contractions (convulsions)
• sensitivity to sunlight or UV lamps
• taste disturbances
• mood changes
• behavior changes
• hair loss
• itchy skin rash
• stomach and/or intestinal bleeding, symptoms may include severe stomach pain, chills, nausea, vomiting, blood or dark particles that look like coffee grounds, heartburn, black tarry stools

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ketoprofeno Dompe

Keep this medication out of sight and reach of children.

Store in the original packaging (envelope or tube) to protect it from light and moisture.

Do not use this medication after the expiration date shown on the packaging, envelope, and tube after CAD. The expiration date refers to the last day of the indicated month.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ketoprofeno Dompe

• The active ingredient is ketoprofen. Each tablet contains 25 mg of ketoprofen as 40 mg of ketoprofen lysine salt.
• The other components are: mannitol (E421), sodium hydrogen carbonate (E500), citric acid (E330), orange flavor, sorbitol (E420), sodium carbonate (E500), leucine, sodium saccharin (E954), polysorbate 20 (E432), simethicone, anhydrous colloidal silica (E551).

Appearance of the product and package contents

Ketoprofeno Dompe effervescent tablets are flat, round, white tablets with an orange flavor. The tablets are supplied in tubes or envelopes of 8, 10, 12, 15, 16, 20, 24 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Dompé farmaceutici S.p.A.

Via San Martino, 12

20122 – Milan

Italy

Manufacturer

E-Pharma Trento S.p.A.

Frazione Ravina

Via Provina, 2

38123 Trento

Italy

This medication is authorized in the EEA member states under the following names:

Netherlands Okitask 25 mg effervescent tablets

Poland Okitask

Finland Okitask 25 mg Effervescent tablets

Hungary Okitask 25 mg effervescent tablet

Italy OKi dolore e febbre 25 mg Effervescent tablets

France Okitask 25 mg Effervescent tablet

Spain Ketoprofeno Dompe 25 mg Effervescent tablet

Portugal Okiact 25 mg Effervescent tablet

Date of the last revision of this leaflet: June 2023

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)